(27 days)
Aesculap's CranioFix 2 System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
The CranioFix 2 Clamp System consists of sterile, titanium implants (Clamps) and associated manual instruments. The Clamps are available in three sizes: 11mm, 16mm, and 20mm. The clamp consists of two concave disks which are connected with a pin through the center. The pin is securely attached to the lower disk; the upper disk is loosely mounted onto the pin. Each disk has rows of teeth extending along the edge of the concave side. The disks are mounted onto the pin with the teeth of each one facing the teeth of the other. The CranioFix 2 Titanium Clamps have a sleeve securely attached on the end of the pin. During the fixation, the lower disk comes to rest against the inner surface of the cranium and the upper disk comes to rest against the outer surface of the cranium.
The provided text describes a 510(k) submission for the CranioFix 2 Titanium Clamp System. This is a medical device, not an AI/ML device, and therefore the majority of the requested information (related to AI performance metrics, sample sizes for training/test sets, ground truth establishment, expert adjudication, MRMC studies) is not applicable.
However, I can extract the relevant information regarding the performance data provided for this physical medical device.
Performance Data for CranioFix 2 Titanium Clamp System
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Equivalent tensile strength to predicate device | Mechanical testing demonstrated equivalent tensile strength to the predicate CranioFix 2 device. |
2. Sample size used for the test set and the data provenance
- Test set sample size: Not specified.
- Data provenance: Not specified, but likely laboratory mechanical testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was mechanical testing, not a study requiring expert clinical assessment/ground truth.
4. Adjudication method for the test set
Not applicable. This was mechanical testing, not a study requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical medical device, not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an AI/ML algorithm.
7. The type of ground truth used
"Equivalent tensile strength to the predicate device" served as the evaluation criterion. This is based on objective mechanical measurements, not expert consensus, pathology, or outcomes data in the traditional sense.
8. The sample size for the training set
Not applicable. This is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a physical medical device, not an AI/ML algorithm.
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K122353
Page 1 of 2
AUG 30 2012
D. SPECIAL 510(k) SUMMARY CRANIOFIX 2 TITANIUM CLAMP SYSTEM
August 3, 2012
| COMPANY: | Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034 |
|---|---|
| CONTACT: | Denise R. Adams, Regulatory Affairs Specialist610-984-9076(phone)610-231-3713 (fax)denise.adams@aesculap.com (email) |
| TRADE NAME: | CranioFix 2 Titanium Clamp System |
| COMMON NAME: | Plate, Cranioplasty, Preformed, Non-alterable |
| REGULATION: | Preformed non-alterable cranioplasty plate |
| PRODUCT CODE: | GXN |
| REGULATION: | 882.5330 |
| REVIEW PANEL: | Neurology |
INTENDED USE
Aesculap's CranioFix 2 System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
DEVICE DESCRIPTION
The CranioFix 2 Clamp System consists of sterile, titanium implants (Clamps) and associated manual instruments. The Clamps are available in three sizes: 11mm, 16mm, and 20mm. The clamp consists of two concave disks which are connected with a pin through the center. The pin is securely attached to the lower disk; the upper disk is loosely mounted onto the pin. Each disk has rows of teeth extending along the edge of the concave side. The disks are mounted onto the pin with the teeth of each one facing the teeth of the other. The CranioFix 2 Titanium Clamps have a sleeve securely attached on the end of the pin. During the fixation, the lower disk comes to rest against the inner surface of the cranium and the upper disk comes to rest against the outer surface of the cranium.
TECHNOLOGICAL CHARACTERISTICS (Compared to Predicate)
The CranioFix 2 Clamp System has the same form, function, and material composition as the predicate CranioFix 2 Clamp System. Several minor modifications were made to the design of the device in order to enhance securement of the top disc and for manufacturability purposes.
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PURPOSE FOR SUBMISSION
The purpose for this special 510(k) submission is to gain marketing clearance for minor modifications to Aesculap's CranioFix 2 Clamp System.
PERFORMANCE DATA
Mechanical testing was performed to ensure that the modified device demonstrated equivalent tensile strength to the predicate CranioFix 2 device.
SUBSTANTIAL EQUIVALENCE
Risk analysis and performance testing demonstrate that the device modifications described in this premarket notification do not raise new questions of safety or effectiveness and therefore are substantially equivalent to the predicate device:
Aesculap CranioFix and CranioFix 2 Titanium Clamp System cleared via K040864.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aesculap, Inc. c/o Ms. Denise R. Adams Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, PA 18034
AUG 300 2012
Re: K122353
Trade/Device Name: CranioFix 2 Titanium Clamp System Regulation Number: 21 CFR 882.5330 Regulation Name: Preformed nonalterable cranioplasty plate Regulatory Class: Class II Product Code: GXN Dated: August 3, 2012 Received: August 3, 2012
Dear Ms. Adams:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Ms. Denise Adams
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcestorYourIndustry/default.htm.
Sincerely vours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear. Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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A. INDICATIONS FOR USE STATEMENT
K122353 510(k) Number (if known):
Device Name: CranioFix 2 Titanium Clamp System
Indication for Use:
Aesculap's CranioFix 2 System is intended for use in the fixation of cranioplasty plates, covering burr holes, and fixation of cranial fractures.
. Or
Prescription Use X
Over-the-Counter Use
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K122353
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).